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无工作经验 -
招1人 -
11-09 发布
- 五险一金
- 补充医疗保险
- 补充公积金
- 员工旅游
- 专业培训
- 弹性工作
- 定期体检
职位描述
职位描述： Key Accountabilities?Support scientific evaluation of safety profiles of assigned products/projects.?Contribute to the development and update of signal detection approaches and assist in authoring signal evaluation reports.?Assists and supports the ongoing aggregate review and analysis of product safety data to maintain up-to-date safety profiles of assigned products/projects throughout their lifecycles?Provide support to related activities such as preparation of ad-hoc and aggregate regulatory reports and labeling support documents?Provide pharmacovigilance input for case series and tabulated data and assist in tracking/evaluation of specific safety topics.?Contribute to preparation and/or presentation of safety review summaries/updates to internal and external stakeholders.?Review of medical and scientific literature relevant to the safety profile of assigned products/projects.?Review of safety data via standard safety database outputs for signal detection?Responsible for quality of medical deliverables working closely with Process Quality Management staff.Skills?Ability to understand, interpret, analyze and clearly present scientific and medical data in verbal and written format (including intermediate understanding and application of medical concepts and terminology.?Extensive medical writing, editing, and source document review?Strong organizational skills, including the ability to prioritize independently with minimal supervision?Ability to digest and apply new knowledge regarding disease entities and pharmaceutical development as related to specific clinical trials.?Ability to communicate clearly and precisely, both orally and in writing.?Research information and prepare written documents.?Keen ongoing interest in medical, pharmaceutical, and regulatory affairs?Basic knowledge of common data processing software (EXCEL, PowerPoint, Microsoft Word, Business Objects).?Able to interact collaboratively and effectively in a team environmentTechnical Skills: Familiarity with industry principles of drug safety, drug development, biostatistics, and epidemiology. Common knowledge of clinical databases and understanding of safety data. Ability to interpret, analyze and clearly present scientific and technical data in verbal and written format. Knowledge of pharmacovigilance regulations and ICH guidelines. Working knowledge of MedDRA terminology and practices.Education?Academic degree in biological or natural science or health care discipline (e.g. PhD, MPH, NP, Pharm D, MSc) (or equivalent work experience).Language Skills?N/AMinimum Work ExperienceMinimum 3 years relevant experience (including industry experience) with drug safety, drug development, regulatory guidelines, and principles of pharmacology and pharmacoepidemiology. 职能类别： 临床研究员
联系方式
沈阳市和平区青年大街286号华润大厦10楼1002室
公司信息
精鼎医药研究开发(上海)有限公司(PAREXEL International)，成立于1982年，是一家致力于药物临床试验研究的CRO (Contract Research Organization)集团公司。总部位于美国，分支机构遍布欧、美、亚、大洋四大洲，且于亚洲13个国家和地区设立了分支机构，致力深耕于当地。精鼎医药由一群具有丰富跨国性临床试验研发经验及专业知识的精英所组成，服务团队集合各种不同专业领域的人才。我们重视与客户的承诺，更重视人才的培育和养成，我们提供完整的教育训练、职涯规划、优于市场的薪资福利、良好工作环境，期许同仁与公司一同成长，迈向未来。 愿景（Vision）： 创造一个在亚太地区具有国际竞争力的最精良CRO团队。 发展使命（Mission）： 1．争取国际大药厂委托，执行符合国际水准的跨国性临床试验。 2．协助亚太生技及制药产业建立新药开发模式，以提升产品研发能力，幷促使产品国际化。 3．以提升临床试验品质为宗旨，拓展全球市场为目标，整合计算机及通讯科技，在国际上提供客户兼具成本效益及效率的临床试验数据处理中心。 4．建立一个以亚洲人种高发生率疾病的基因数据库，以提供国际性新药研发机构所须之基因信息，协助其缩短药物开发时程，幷提高研发成功率。 公司福利和人才培养计划： 保险类： 1. 社会保险(依照国家规定)及住房公积金； 2. 团体保险（包括寿险、意外暨医疗保险）； 3. 补充医疗保险； 制度类： 1. 学习发展计划 (Learning & Development): 针对个别员工之专业及兴趣，设计符合其个人之生涯规划； 2. 完整的教育训练：每年公司均针对所有员工，提供完整之教育训练； 3. 顺畅的升迁管道及可转调其它部门；如有职缺，亦可申请调至海外各子公司； 请 / 休假制度： 1. 服务第一年即享有14天年假, 后续年休假天数则依据服务年资及公司制度而定； 2. 一年可享12天不扣薪病假； 3. 员工旅游, 年度体检； 精鼎医药将以培养国际性的人才为目标，欢迎具有国际观之人才加入。 应聘方法： 1. 在线投递； 2. 请登录我们的公司网站直接投您的简历（https://jobs.parexel.com/search-jobs） 我们在收到您的简历之后，会尽快与您联系。 谢谢！
